Active Ingredients
Allantoin 1% .................................................................................................. Skin Protectant
Earthmed Lip Balm Peppermint Salve
FDA Label NDC 82876-990
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Earthmed Llc for the product Earthmed Lip Balm Peppermint (NDC 82876-990). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, when using this product, otc - do not use, stop use and ask a doctor if, if pregnant or breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Allantoin 0.72% .................................................................................................. Skin Protectant
Uses
helps prevent and temporarily protects and helps relieve chafed, chapped, or
cracked skin • helps prevent and protect from the drying effects of wind and cold weather
Warnings
FOR EXTERNAL USE ONLY.
When Using This Product
Do not get into eyes
Otc - Do Not Use
on deep or puncture wounds • animal bites • serious burns
Stop Use And Ask A Doctor If
The condition worsens, symptoms last more than 7 days, the condition clears but occurs again within a few days.
Condition worsens, Symptoms last more than 7 days, Condition clears up but occurs again within a few days.
If Pregnant Or Breastfeeding
Consult a health professional before use
In Case Of An Overdose
seek medical help or contact a poison control center right away
Directions
• Adults and children 2 years of age and older: Apply as needed
• Children under 2 years of age: Do not use, consult a doctor
Keep Out Of Reach Of Children
keep out of reach of children
keep out of reach of children
Other Information
Store at 68-77 degrees F, Avoid direct sunlight
Inactive Ingredients
Beeswax, Coconut oil, Ethanol, Full Spectrum Hemp oil, Natural Flavor, Sweet Almond oil,
Rice bran oil, Stevia extract
Package Label.Principal Display Panel
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